Jane McCredie: Patent genie is out

THE basis of Australian patent law is the 1623 Statute of Monopolies, an English law designed to rein in the royal power to grant monopolies that were often used as a means of raising funds or rewarding loyal subjects.

Patents granted by Elizabeth I and James I had caused considerable unrest, particularly when they were alleged to be granted for everyday commodities such as glass or salt.

The resulting law declared monopolies were to be granted to “the first and true inventor” of “any manner of new manufacture”, ushering in the modern patent system.

Nearly 400 years later, we’re still arguing over the meaning of that 17th century attempt to address issues of corruption and market manipulation.

The Australian Federal Court this month ruled on a case challenging a private company’s patent over human genetic material, specifically the BRCA1 gene, mutations of which are implicated in familial breast and ovarian cancer.

The court dismissed the case, finding isolated human DNA or RNA could be considered “a manner of manufacture” as required under patent law.

My instinctive response — shared with many people, I suspect — is to say this is outrageous. As I wrote in MJA InSight last year, it seems intuitively wrong that any individual enterprise should be able to claim ownership over part of the human genome.

There is, it seems, something particularly abhorrent to us about the idea that somebody — anybody — can claim ownership over our genes, those hidden recipes that encode our very identity.

But that’s more a cry of outrage than a rational objection.

I have to admit I don’t have the same knee-jerk response to the idea of a patent being granted over a chemical isolated from nature, despite it arguably raising exactly the same question of whether something that occurs naturally should ever be the subject of a patent.

So, it might be more useful to talk about the inherent purposes of patent law and whether current applications of it are serving them.

Patents are designed to foster innovation by rewarding those responsible for it. But they should also, as the 17th century drafters of the Statute of Monopolies believed, provide a benefit to society as a whole.

And that’s where the patenting of genetic material becomes problematic since, if it prevents other researchers from working on a particular gene, it can actually prevent further breakthroughs with all the benefits they might bring to patients.

In the case of BRCA1, it’s been suggested patenting of the gene has inhibited research into screening and genetic therapies as well as driving up costs for patients.

It might have made more sense for patents to be granted over methods of isolating a gene, or applications of the isolated gene (such as a specific screening test), than over the genes themselves.

But the problem is we’re having this conversation way too late.

The first patents over human genes go back to the 1980s and one of the considerations courts and legislators around the world now take into account is that an entire biotech industry has been built on the basis that isolated genetic material can become the property of those who develop it.

Changing that legal framework would have huge ramifications for that industry and not all the consequences would be good.

The Australian Law Reform Commission concluded nearly a decade ago that, although there were attractive arguments against allowing patenting of biological materials that occurred in nature, the time when such an approach might have been possible had long passed.

So many patents now existed that an attempt to change the laws could have untold consequences for industry and scientific research more generally, the report suggested.

Unpalatable as it may be, it seems you can’t put the genie back in the bottle.

Perhaps the focus should now shift to how we ensure researchers have access to those patented genes so the law can achieve its aim of fostering innovation rather than stifling it.

Jane McCredie is a Sydney-based science and medicine writer.

Posted 25 February 2013